Kornimate/medical-research-clean huggingface dataset:
measuring svap-1 as a predictor of pregnancy problems

Conditions: Pregnancy Complications

Summary: pre-eclampsia is a common pregnancy disorder defined as high blood pressure and protein in the urine after 20 weeks of pregnancy. it affects the function of the placenta and can cause severe complications, e.g, stroke, multiple organ damage and seizures for the mother, and fetal growth restriction or stillbirth for the baby. pre-eclampsia can also cause long term health problems for mother and baby. currently, there is no test that can predict whether someone will develop pre-eclampsia, so nothing is done to intervene before the problems begin. results from their previous work suggest that the investigators may have found something that can be measured in a blood sample that can predict which women might develop pre-eclampsia. it is a protein known as vascular adhesion protein-1 (vap-1), and our evidence points at it being involved in the embryo attaching to the womb and also in helping the development of the placenta by helping to get the right cells to where they are needed. the investigators will test blood samples from 451 pregnant women who come to the leicester royal infirmary for routine bloods and their first pregnancy dating scan. the investigators will then follow the outcomes of the pregnancy to see if vap-1 in the blood of women who develop pre-eclampsia (or other pregnancy complications) is different from the ones who do not develop pregnancy complications. the ability to predict women at higher risk of pregnancy complications would ensure the application of timely interventions and appropriate management of the conditions that may help to prevent complications both during pregnancy and later life. the study is expected to last approximately 30 weeks and the participants will be asked to give one extra tube of blood whilst having their routine bloods taken and to also consent to follow up of medical records until the end of the pregnancy.


Eligibility criteria:
inclusion criteria: * female participants who are in early pregnancy (\<20 weeks gestational age). * 16 years and above * patient consents to take part in the study exclusion criteria: * patient declines to be involved in the study * unsuccessful venepuncture

Keywords: hypertension in pregnancy pre-eclampsia gestational diabetes fetal growth restriction large for gestational age stillbirth miscarriage
opioid vs. benzodiazepine-based sedation for mechanically ventilated patients in the internal medicine ward

Conditions: Mechanically Ventilated Patients

Summary: opioid-based sedation as a first line in mechanically ventilated patients has been considered the "gold standard" in intensive care unit patients around the world for several decades. advantages of opiate-based sedation, compared to benzodiazepine-based sedation, which has been used in the past, include a reduction in delirium scores, better pain control, decreasing the time between cessation of sedation and patient awakening, and decreasing the time between cessation of sedation and extubation, with decreased icu admission times. in most western european countries, as well as in the united states, there are almost no mechanically ventilated patients hospitalized outside the intensive care unit. in a few countries, including japan and israel, mechanically ventilated patients are also hospitalized outside of intensive care units, as part of internal or surgical wards. contrary to the vast knowledge accumulated regarding different sedation methods in ventilated patients in intensive care units, there are almost no studies that have evaluated different sedation methods in ventilated patients hospitalized in non-intensive care wards. thus, while there is consensus on the benefits of opioid-based sedation in intensive care units, there is insufficient information to recommend the preferred sedation method in non-icu wards. for various reasons, in a large number of the internal medicine wards of hospitals in israel, the common sedation practice for ventilated patients is still benzodiazepine-based sedation. in the past year, a pilot program was initiated in internal medicine department a at meir hospital in kfar saba, in which a new protocol for opioid-based sedation in ventilated patients was implemented. the protocol is based on the continuous intravenous infusion of fentanyl as the first line of treatment for sedation in ventilated patients only. if the sedation-agitation level (as measured by the rass score) did not match the target rass score set by the attending physician, a dose up to a maximum limit could be increased according to the protocol. second-line sedation drugs were addition of continuous intravenous infusion of midazolam (in addition to fentanyl) in hemodynamically stable patients, or addition of continuous intravenous infusion of ketamine in unstable patients. in stable patients who did not reach the desired rass level under continuous infusion of fentanyl and midazolam, ketamine could be added as a third line drug, in addition to fentanyl and midazolam.


Eligibility criteria:
inclusion criteria: patients aged 18-99 who were admitted to internal medicine department a at meir hospital in kfar saba from january 2020 to january 2021 (inclusive), and required mechanical ventilation. - exclusion criteria: patients who were sedated and ventilated for palliative care only without any fututre plan for weaning them of ventilation, or patients in whom there was a deviation from the treatment protocol -

Keywords: opioid-based sedation, delirium
a clinical study to compare combination of aliskiren+ hctz to irbesartan+ hctz or amlodipine+ hctz or hctz alone in obese hypertensive not responsive to hctz 25 mg

Conditions: Hypertension

Summary: to evaluate the blood pressure lowering effects of the combination of aliskiren 300 mg and hctz 25 mg in obese patients with essential hypertension inadequately treated with hctz 25 mg, compared to irbesartan or amlodipine with hctz or hctz alone.


Eligibility criteria:
inclusion criteria * patients with essential hypertension * patients with body mass index ≥ 30 kg/m2 exclusion criteria * severe hypertension * history or evidence of a secondary form of hypertension * history of hypertensive encephalopathy or cerebrovascular accident. other protocol-defined inclusion exclusion criteria also apply.

Keywords: hypertension, aliskiren, blood pressure, irbesartan, amlodipine, hydrochlorothiazide
a study of edg-5506 in adult males with becker muscular dystrophy

Conditions: Becker Muscular Dystrophy

Summary: the arch study is an open-label, single-center, phase 1b study of sevasemtem (edg-5506) to assess the safety and pharmacokinetics (pk) of sevasemten in adults with becker muscular dystrophy (bmd). sevasemten is an investigational product intended to protect and improve function of dystrophic muscle fibers.

this open-label study will evaluate the safety, tolerability, and pharmacokinetics (pk) of sevasemten in participants with bmd who completed the first-in-human study, edg-5506-001, as well as additional (treatment-naïve) participants from outside the edg-5506-001 study to meet the target sample size. all participants will receive sevasemten. on-site visits will occur approximately monthly for the first 12 months, followed by every 3 months to assess safety and measures of function. this study will have a 24 month treatment period, followed by a 4 week follow-up period.

Eligibility criteria:
inclusion criteria: 1. participants who have completed study edg-5506-001. 2. participants who were not from study edg-5506-001 must meet the following: 1. male sex at birth and aged 18 to 55 years inclusive at time of consent. 2. documented dystrophin mutation with phenotype consistent with bmd. 3. ambulatory at screening (defined as ability to complete 100 meter \[m\] timed test, with or without assistance). 4. body weight ≥ 50 kg at the screening visit. 5. body mass index (bmi) between 20 and 34 kg/m2 inclusive. exclusion criteria: 1. receipt of oral corticosteroids for \>5 days in the previous 6 months at a dose of \>5 mg equivalent per day. lower oral doses or inhaled/intranasal steroids are permitted. 2. receiving moderate or strong cytochrome p450 cyp3a4 inhibitors or inducers. 3. participation in any other investigational drug study or use of use of an investigational drug within 30 days or 5 half-lives (whichever is longer) of dosing in the present study. 4. medical history or other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory result or abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. includes venous access that would be too difficult to facilitate repeated blood sampling.

Keywords: becker muscular dystrophy
premenstrual syndrome in young women with eight weeks of aerobic exercise

Conditions: Aerobic Exercise; Premenstrual Syndrome

Summary: the premenstrual syndrome includes physical and psychological symptoms that occur at the end menstrual cycle and exercise is one of the ways to reduce symptoms. the aim of this study was to determine the effect of a regular 8-week aerobic exercise program on psychological symptoms of premenstrual syndrome.

premenstrual syndrome is characterized by the presence of both physical and behavioral (including affective) symptoms that occur repetitively in the second half of the menstrual cycle and interfere with some aspects of the woman's life(1). the core symptoms of pms include affective symptoms, such as irritability, depression, anxiety, and somatic symptoms, such as breast pain, bloating, swelling, and headache (2). women with moderate to severe pms symptoms had a reduction in health-related quality of life(3) and work productivity, increased work absenteeism, and visits to ambulatory healthcare providers (4), so the treatment of this syndrome is essential.

Eligibility criteria:
inclusion criteria: * young women aged 18-25 years with a body mass index (bmi): 18-25 kg/m2, having regular menstrual cycles of 23-35 days duration, no previous practice of aerobic exercise, free from musculoskeletal injury, not using oral contraceptive pills or taking any psychotropic agents, having no depression or genital tract diseases exclusion criteria: * pregnancy, contraindications to physical exercise, metabolic or cardiorespiratory illness, cigarette smokers, women who recover from a major injury or using anti-inflammatory, hyperlipidemia or hypertension medications, any abnormality in ovulation, and women with diabetes mellitus, thyroid, pituitary, or ovarian disorders
a comparison of 882c87 versus acyclovir in the treatment of herpes zoster in patients with weakened immune systems

Conditions: HIV Infections; Chickenpox

Summary: to determine the efficacy of oral 882c87 compared with oral acyclovir in the treatment of localized herpes zoster in immunocompromised patients. to assess the safety and tolerance of oral 882c87 in immunocompromised patients.

patients are randomized to receive either 882c87 or acyclovir with corresponding placebos for 14 days, with two hundred patients in each of the two groups. they are stratified by presence or absence of hiv infection. patients undergo 6 months of follow-up.

Eligibility criteria:
inclusion criteria patients must have: * acute localized herpes zoster or rash present less than 72 hours, verified by clinical diagnosis. * immunocompromised condition primarily as a result of documented hiv infection, malignancy, chemotherapy or radiation therapy, solid organ or bone marrow transplant, or chronic immunosuppressive therapy. * life expectancy of at least 6 months. * ability to cooperate with the requirements of the study. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * evidence of cutaneous or visceral dissemination (more than 20 discrete lesions outside adjacent dermatomes). * acute, life-threatening condition. * significant malabsorption syndrome or other gastrointestinal dysfunction that may severely reduce drug absorption. * intolerance of oral medication. concurrent medication: excluded: * tricyclic antidepressants or anti-epileptics. * topical applications to the zoster lesions that would obscure evaluation. * fluorouracil and flucytosine. * systemic therapy with agents with antiherpetic activity (from 2 weeks prior to first dose to day 28 of study). * probenecid or other drugs likely to affect elimination of study drugs (from 2 days prior to first dose to day 14 of the study). * capsaicin (zostrix). * warfarin (coumadin) during 14 days of treatment. patients with the following prior conditions are excluded: history of intolerance, hypersensitivity, or severe drug reaction to acyclovir. prior medication: excluded: * systemic therapy with agents with antiherpetic activity (including interferon) within the past 2 weeks. * probenecid or other drugs likely to affect the elimination of 882c87 or acyclovir within the past 48 hours. * drugs likely to interact with 882c87 (e.g., fluorouracil or flucytosine) within the past 7 days. * zoster immune globulin or zoster immune plasma within the previous month. history of alcohol or drug abuse within the previous 6 months or current methadone therapy.

Keywords: herpes zoster acyclovir acquired immunodeficiency syndrome aids-related complex antiviral agents
single-dose pk study of gbt440 in subjects with renal impairment

Conditions: Renal Impairment

Summary: a phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral dose of gbt440 administered in subjects with mild, moderate, or severe renal impairment disease and healthy subjects with normal renal function.

up to 40 adult subjects will be enrolled. safety and pk assessments will be performed at selected time points throughout the study.

Eligibility criteria:
inclusion criteria: all subjects: * males or females, 18 to 80 years old * willing and able to give written informed consent subjects with renal impairment: * severe renal impairment (egfr \< 30 ml/min/1.73m2, not on dialysis) * moderate renal impairment (30 ml/min/1.73m2 = or \< egfr \< 60 ml/min/1.73m2) * mild renal impairment (60 ml/min/1.73m2 = or \< egfr \< 90 ml/min/1.73m2) healthy subjects: * match in age, gender and body mass index with renal impaired subjects * healthy and without clinically significant abnormalities in vital signs, ecgs, physical exam, clinical laboratory evaluations, medical and surgical history exclusion criteria: all subjects: * participation in another clinical trial of an investigational drug (or medical device) within 30 days of the last dose of investigational drug or 5 half lives whichever is longer, prior to screening, or is currently participating in another trial of an investigational drug (or medical device) * any signs or symptoms of acute illness at screening or day -1 * history or presence of clinically significant allergic, hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease subjects with renal impairment: - history of clinically significant hepatic disease e.g. hepatitis, cirrhosis and or liver enzymes (alt, ast, ggt and total bilirubin) \> 5 times the upper limit of normal within the past year
a study of mci-196 in chronic kidney disease stage v subjects on dialysis with hyperphosphatemia

Conditions: Chronic Kidney Disease; Dialysis; Hyperphosphatemia

Summary: this is a piii multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the e07(nct00416520), e08(nct00542386) and e09(nct00451295) studies will allow exposure to mci-196 for up to 52 weeks

following completion of one of the phase iii studies (e07, e08 or e09) eligible patients will receive either mci-196 for up to 52 weeks. the study is in two periods. the initial period allows flexible dosing for a period of 8 weeks. this will allow subjects to achieve individually optimised doses. after 8 weeks, subjects will continue flexible dosing with mci-196 but with titration intervals every 4 weeks instead of every 2 weeks. subjects previously exposed to mci-196 will end the study at week 40.

Eligibility criteria:
inclusion criteria: * clinically stable haemodialysis or peritoneal dialysis treatment. * stable phosphate control * stabilised phosphorus diet. * female subjects of child-bearing potential must have a negative serum pregnancy test. * male subjects must agree to use appropriate contraception. * completed one of the mci-196 piii studies exclusion criteria: * current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose them to undue risk, or interfere significantly with study procedures and which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study. * body mass index (bmi) \ 40.0 kg/m2. * current or a history of significant gastrointestinal motility problems * positive test for hiv 1 and 2 antibodies. * history of substance or alcohol abuse within the last year. * seizure disorders. * history of drug or other allergy. * temporary catheter with active signs of inflammation or infection. * the subject has participated in a clinical study with any experimental medication (with the exception of mci-196 piii studies) in the last 30days or experimental biological product within the 90 days prior to signing of informed consent form.

Keywords: chronic kidney disease dialysis hyperphosphatemia
digital mindfulness-based treatment for substance use disorder recovery

Conditions: Substance Use Disorders

Summary: the goal of this clinical trial is to evaluate the feasibility and acceptability of a digital mindfulness-based treatment for individuals in early recovery from substance use disorders. participants are randomized to treatment-as-usual (tau) or tau plus the digital mindfulness-based treatment. the digital treatment will be completed over an 8-week period.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * fluent in english and have a 6th grade or higher reading level * have completed 1 month or more of sud treatment * report use of their primary substance of choice in past 6 months * are not currently enrolled in residential/inpatient treatment * are willing to be randomized * are willing and able to participate for the entire study period * are willing to provide locator information for follow-up * own a working, wifi-enabled smartphone exclusion criteria: * current psychotic disorder * high suicide risk characterized by suicidal ideation with intent * homicidal ideation posing imminent danger to others * pending legal case, imminent incarceration, or a planned move that results in inability to commit to procedures during the entire study period * participation in the phase 1 user testing study
a trial in healthy volunteers, to evaluate the tolerability and cardiac safety of prucalopride

Conditions: Constipation

Summary: an escalating dose of prucalopride up to a maximum of 20 mg was given once daily to 32 healthy volunteers to determine safety at the maximum tolerable dose or at 20 mg.

this is a single-centre, double-blind, placebo-controlled, cross-over trial in 32 healthy volunteers with two sessions (i and ii). each session consists of a run-in day for baseline assessments, 13 treatment days and 5 additional days for assessments. subjects will be randomized to start with either the prucalopride or placebo session. between the 2 sessions, there will be a washout period of 14 to 21 days, to avoid any carry-over effect.

Eligibility criteria:
inclusion criteria: 1. aged between 18 and 45 years, extremes included. 2. subject has a normal weight as defined by a quetelet index range of 18 - 30 kg/m2, extremes included. 3. informed consent form signed and dated, prior to screening. 4. healthy on the basis of a pre-trial physical examination, medical history, anamnesis, electrocardiogram, 24 hour holter monitoring and the results of blood biochemistry and haematology tests and a urinalysis carried out in 3 weeks preceding randomization. exclusion criteria: 1. history or suspicion of alcohol, barbiturate, amphetamine or narcotic abuse. 2. smoking more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 6 months prior to selection. 3. history of cardiac arrhythmia's, bronchospastic or cardiovascular disease (e.g. ischemic heart disease or cerebrovascular accident), diabetes mellitus, thyrotoxicosis, parkinsonism, drug allergy. 4. presence of prolonged qtc (bazett) on ecg at screening (qtc \> 450 msec in male subjects, qtc \> 470 msec in female subjects). 5. use of concomitant medication, except for oral contraceptives and paracetamol. all other medication must have been stopped at least 14 days before the first dose. 6. participation in an investigational drug trial in 30 days prior to the first visit. 7. donation of blood in the 60 days preceding the first visit. 8. pregnancy (as confirmed by a hcg test during screening and at day 0 of each treatment session) or breast-feeding female. 9. subjects with positive results for hiv, hepatitis b or c at screening. 10. female subjects of childbearing potential without adequate contraceptive protection during the trial.

Keywords: constipation prucalopride mtd cardiovascular safety
comparison of dexamethasone added to ropivacaine and ropivacaine alone in caudal analgesia in children undergoing orchiopexy

Conditions: Cryptorchidism

Summary: single shot caudal epidural block is one of the most widespread technique for pediatric pain management after infraumbilical surgical procedures. however, in a significant proportion of patients, despite good initial analgesia from a caudal block with local anesthetic, pain develops after the block resolves. in order to decrease postoperative analgesic requirements after caudal block, various drugs such as opioids, ketamine, clonidine, or dexmedetomidine to local anesthetics has been investigated. however, their use has been limited by adverse effects in children. recently, many study suggested that epidurally administered dexamethasone could reduce the incidence and severity of postoperative pain in adults. but there is no study concerning the use of dexamethasone, as an adjuvant agent for the caudal epidural block in children. the investigators performed prospective randomized double-blind study to examine the analgesic effect of dexamethasone added to ropivacaine and ropivacaine alone in caudal analgesia on postoperative pain control in pediatric patients undergoing orchiopexy. 80 children (aged 0.5-5 yr) undergoing day-case orchiopexy were included in this prospective, randomized, double-blinded study. after inhalation induction of general anesthesia, caudal block was applied. patients were randomly assigned in two groups. normal saline 0.02ml/kg added to ropivacaine 0.15% 1.5ml/kg was administered to group r , dexamethasone 0.1mg/kg added to ropivacaine 0.15% 1.5ml/kg to group dr. postoperative pain was recorded at 30min and 1,2,3 h by using hospital of eastern ontario pain scale (cheops, 0-10) and faces legs activity cry consolability tool (flacc, 0-10). participants will be followed for the duration of hospital stay, an expected average of 3 hours. after discharge, rescue analgesic consumption, pain scores, and adverse effects were evaluated for 24h. the time to first supplemental oral analgesic medication demand was defined as the time from the end of surgery to the first registration of a vas ( 0-10) ≥ 5 by parent's observation. twenty-four hours after surgery, reports of delayed side effects and demands for rescue analgesics from the child were gathered from parents via a telephone interview.


Eligibility criteria:
inclusion criteria: * asa status i-ii * children aged 6 months to 5 years * undergoing day-case unilateral orchiopexy exclusion criteria: * hypersensitivity to any local anesthetics * bleeding diathesis * infections at puncture sites * preexisting neurological disease * diabetes mellitus